510(k) · Cleared
ClearedLensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bonraybio Co., Ltd. · POV Semen Analysis Device
Cleared on May 30, 2025 as substantially equivalent to K202089 (Bonraybio Co., Ltd., 2020) after a 253-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- May 30, 2025
- Review
- 253 days
- Class
- Class II
- Product code
- POV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K021746 (2002). No later device cites it as a predicate yet.
- Root · 3 generations backK021746 Sqa V, Sperm Quality AnalyzerMedical Electronic Systems, LLC · 2002
- 2 generations backK180343 LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality…Bonraybio Co., Ltd. · 2018
- 1 generation backK202089 LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen…Bonraybio Co., Ltd. · 2020
- This deviceK242830 LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen…Bonraybio Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K021746 | Sqa V, Sperm Quality Analyzer | Medical Electronic Systems, LLC | 2002 | — |
| −2 | K180343 | LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer | Bonraybio Co., Ltd. | 2018 | — |
| −1 | K202089 | LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality… | Bonraybio Co., Ltd. | 2020 | — |
| 0 (this device) | K242830 | LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality… | Bonraybio Co., Ltd. | 2025 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in POV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new POV device
- #1 K252228 Seaman Pro/Seamanscore 11.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K202089 | LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality AnalyzerSummary page 9…y Analyzer are substantially equivalent to： LensHooke X1 PRO and X1 PRO SE Semen Quality Analyzer Device Company: Bonraybio Co., LTD. 510(k) Number: K202089 7 Comparison to Predicate Device: 7.1 LensHooke X3 PRO Semen Quality Analyzer: LensH… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K202089.
How does its category compare?
All POV devicesPOV Semen Analysis Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · POV
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · POV
253in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · POV
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · POV
1in 2020
MAUDE reports naming product code POV, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 3 | 253 | 2 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
For Over-the-Counter Setting: The LensHooke® X3 PRO SE Semen Quality Analyzer used with LensHooke® Semen Test Cassette is an optical device for human semen analysis which provides direct and calculated quantitative measurements for: (1) Sperm concentration (M/mL) (2) Total motility (PR+NP, %) - Progressive motility (%) - Non-Progressive motility (%) - Immotility (%) (3) Sperm morphology (normal forms, %) (4) pH value The LensHooke® X3 PRO SE Semen…
Read the full statement (201 words)
For Over-the-Counter Setting:
The LensHooke® X3 PRO SE Semen Quality Analyzer used with LensHooke® Semen Test Cassette is an optical device for human semen analysis which provides direct and calculated quantitative measurements for:
(1) Sperm concentration (M/mL)
(2) Total motility (PR+NP, %)
- Progressive motility (%)
- Non-Progressive motility (%)
- Immotility (%)
(3) Sperm morphology (normal forms, %)
(4) pH value
The LensHooke® X3 PRO SE Semen Quality Analyzer does not provide a comprehensive evaluation of a male’s fertility status. It is a self-testing diagnostic system intended for human semen analysis of individuals at home to evaluate male fertility.
For Point-of-Care Professional Setting:
The LensHooke® X3 PRO Semen Quality Analyzer used with LensHooke® Semen Test Cassette is an optical device for human semen analysis which provides direct and calculated quantitative measurements for:
(1) Sperm concentration (M/mL)
(2) Total motility (PR+NP, %)
- Progressive motility (%)
- Non-Progressive motility (%)
- Immotility (%)
(3) Sperm morphology (normal forms, %)
(4) pH value
The LensHooke® X3 PRO Semen Quality Analyzer does not provide a comprehensive evaluation of a male’s fertility status. It is an in-vitro diagnostic system intended for human semen analysis of individuals in healthcare professional setting to evaluate male fertility.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242830 · printed Nov 5, 2026
Cite this page
510(k) Report. “K242830: LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K242830
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026